SUPPLY CHAIN ARTICLES

  • “To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles

    In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

  • The Expanding Patent Landscape For RNA-Based Therapeutics

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

    mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

  • A "Hot Take" on Personalized mRNA Medicines

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

  • Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

SUPPLY CHAIN VIDEOS

Explore critical steps and key regulatory requirements for developing CRISPR therapeutics and gain practical advice on how to avoid common pitfalls.

In response to an audience poll question gauging which cGMP materials have proven the most difficult to source, our speakers provide additional clarity around which IVT & LNP-related materials today are more “commoditized”.

Looking to enhance performance and manufacturing from your DNA backbone without the regulatory concerns? Gain advantages over legacy plasmid DNA backbones and minicircles.

Review data and evidence that demonstrates the benefits of an integrated approach to achieving critical end-user goals such as scalability, efficiency, sustainability, and optimized process economics.

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